Federal Register / Vol. 86, No. 132 / Wednesday, July 14, 2021 / Notices 37159 

moved the drug product to the 

‘‘Discontinued Drug Product List’’ 

section of the Orange Book. 

Foley and Lardner, LLP submitted a 

citizen petition dated February 16, 2021 

(Docket No. FDA–2021–P–0191), under 

21 CFR 10.30, requesting that the 

Agency determine whether 

STROMECTOL (ivermectin) tablets, 6 

mg, were withdrawn from sale for 

reasons of safety or effectiveness. 

After considering the citizen petition 

and reviewing Agency records and 

based on the information we have at this 

time, FDA has determined under 

§ 314.161 that STROMECTOL 

(ivermectin) tablets, 6 mg, were not 

withdrawn for reasons of safety or 

effectiveness. The petitioner has 

identified no data or other information 

suggesting that STROMECTOL 

(ivermectin) tablets, 6 mg, were 

withdrawn for reasons of safety or 

effectiveness. We have carefully 

reviewed our files for records 

concerning the withdrawal of 

STROMECTOL (ivermectin) tablets, 6 

mg, from sale. We have also 

independently evaluated relevant 

literature and data for possible 

postmarketing adverse events. We have 

reviewed the available evidence and 

determined that this drug product was 

not withdrawn from sale for reasons of 

safety or effectiveness. 

Accordingly, the Agency will 

continue to list STROMECTOL 

(ivermectin) tablets, 6 mg, in the 

‘‘Discontinued Drug Product List’’ 

section of the Orange Book. The 

‘‘Discontinued Drug Product List’’ 

delineates, among other items, drug 

products that have been discontinued 

from marketing for reasons other than 

safety or effectiveness. ANDAs that refer 

to STROMECTOL (ivermectin) tablets, 6 

mg, may be approved by the Agency as 

long as they meet all other legal and 

regulatory requirements for the approval 

of ANDAs. If FDA determines that 

labeling for this drug product should be 

revised to meet current standards, the 

Agency will advise ANDA applicants to 

submit such labeling. 

Dated: July 7, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–14935 Filed 7–13–21; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2019–D–3361] 

Eligibility Criteria for Expanded 

Conditional Approval of New Animal 

Drugs; Guidance for Industry; 

Availability 

AGENCY: Food and Drug Administration, 

Health and Human Services (HHS). 

ACTION: Notice of availability. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing the availability of final 

guidance for industry (GFI) #261 

entitled ‘‘Eligibility Criteria for 

Expanded Conditional Approval of New 

Animal Drugs.’’ This guidance is 

intended for sponsors and potential 

sponsors who may be interested in 

pursuing conditional approval of new 

animal drugs for certain major uses in 

major species. Eligibility for conditional 

approval has been expanded beyond 

minor uses in major species and use in 

minor species (MUMS) to include 

certain major uses in major species. The 

Center for Veterinary Medicine (CVM or 

we) refers to the process for 

conditionally approving new animal 

drugs that are not intended for MUMS 

indications as ‘‘expanded conditional 

approval.’’ The purpose of expanded 

conditional approval is to incentivize 

development of new animal drugs for 

serious or life-threatening conditions or 

unmet animal or human health needs 

under circumstances where a 

demonstration of effectiveness would 

require a complex or particularly 

difficult study or studies. This guidance 

defines certain terms, clarifies the 

eligibility criteria for expanded 

conditional approval, and describes the 

criteria CVM intends to consider when 

determining expanded conditional 

approval eligibility. 

DATES: The announcement of the 

guidance is published in the Federal 

Register on July 14, 2021. 

ADDRESSES: You may submit either 

electronic or written comments on 

Agency guidances at any time as 

follows: 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: 

https://www.regulations.gov. Follow the 

instructions for submitting comments. 

Comments submitted electronically, 

including attachments, to https://

www.regulations.gov will be posted to 

the docket unchanged. Because your 

comment will be made public, you are 

solely responsible for ensuring that your 

comment does not include any 

confidential information that you or a 

third party may not wish to be posted, 

such as medical information, your or 

anyone else’s Social Security number, or 

confidential business information, such 

as a manufacturing process. Please note 

that if you include your name, contact 

information, or other information that 

identifies you in the body of your 

comments, that information will be 

posted on https://www.regulations.gov. 

• If you want to submit a comment 

with confidential information that you 

do not wish to be made available to the 

public, submit the comment as a 

written/paper submission and in the 

manner detailed (see ‘‘Written/Paper 

Submissions’’ and ‘‘Instructions’’). 

Written/Paper Submissions 

Submit written/paper submissions as 

follows: 

• Mail/Hand Delivery/Courier (for 

written/paper submissions): Dockets 

Management Staff (HFA–305), Food and 

Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852. 

• For written/paper comments 

submitted to the Dockets Management 

Staff, FDA will post your comment, as 

well as any attachments, except for 

information submitted, marked and 

identified, as confidential, if submitted 

as detailed in ‘‘Instructions.’’ 

Instructions: All submissions received 

must include the Docket No. FDA– 

2019–D–3361 for ‘‘Eligibility Criteria for 

Expanded Conditional Approval of New 

Animal Drugs.’’ Received comments 

will be placed in the docket and, except 

for those submitted as ‘‘Confidential 

Submissions,’’ publicly viewable at 

https://www.regulations.gov or at the 

Dockets Management Staff between 9 

a.m. and 4 p.m., Monday through 

Friday, 240–402–7500. 

• Confidential Submissions—To 

submit a comment with confidential 

information that you do not wish to be 

made publicly available, submit your 

comments only as a written/paper 

submission. You should submit two 

copies total. One copy will include the 

information you claim to be confidential 

with a heading or cover note that states 

‘‘THIS DOCUMENT CONTAINS 

CONFIDENTIAL INFORMATION.’’ The 

Agency will review this copy, including 

the claimed confidential information, in 

its consideration of comments. The 

second copy, which will have the 

claimed confidential information 

redacted/blacked out, will be available 

for public viewing and posted on 

https://www.regulations.gov. Submit 

both copies to the Dockets Management 


lotter on DSK11XQN23PROD with NOTICES1
37160 Federal Register / Vol. 86, No. 132 / Wednesday, July 14, 2021 / Notices 

Staff. If you do not wish your name and 

contact information to be made publicly 

available, you can provide this 

information on the cover sheet and not 

in the body of your comments and you 

must identify this information as 

‘‘confidential.’’ Any information marked 

as ‘‘confidential’’ will not be disclosed 

except in accordance with 21 CFR 10.20 

and other applicable disclosure law. For 

more information about FDA’s posting 

of comments to public dockets, see 80 

FR 56469, September 18, 2015, or access 

the information at: https://

www.govinfo.gov/content/pkg/FR-2015- 

09-18/pdf/2015-23389.pdf. 

Docket: For access to the docket to 

read background documents or the 

electronic and written/paper comments 

received, go to https://

www.regulations.gov and insert the 

docket number, found in brackets in the 

heading of this document, into the 

‘‘Search’’ box and follow the prompts 

and/or go to the Dockets Management 

Staff, 5630 Fishers Lane, Rm. 1061, 

Rockville, MD 20852, 240–402–7500. 

You may submit comments on any 

guidance at any time (see 21 CFR 

10.115(g)(5)). 

Submit written requests for single 

copies of the guidance to the Policy and 

Regulations Staff (HFV–6), Center for 

Veterinary Medicine, Food and Drug 

Administration, 7500 Standish Pl., 

Rockville, MD 20855. Send one selfaddressed adhesive label to assist that 

office in processing your requests. See 

the SUPPLEMENTARY INFORMATION section 

for electronic access to the guidance 

document. 

FOR FURTHER INFORMATION CONTACT: 

Christopher Loss, Center for Veterinary 

Medicine (HFV–116), Food and Drug 

Administration, 7500 Standish Pl., 

Rockville, MD 20855, 240–402–0619, 

christopher.loss@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In the Federal Register of September 

30, 2019 (84 FR 51594), FDA published 

the notice of availability for a draft 

guidance entitled ‘‘Eligibility Criteria for 

Expanded Conditional Approval of New 

Animal Drugs’’ giving interested 

persons until January 28, 2020, to 

comment on the draft guidance. FDA 

received a few comments on the draft 

guidance and those comments were 

considered as the guidance was 

finalized. Editorial changes were made 

to improve clarity. The guidance 

announced in this notice finalizes the 

draft guidance dated September 2019. 

This level 1 guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The guidance represents the current 

thinking of FDA on eligibility criteria 

for expanded conditional approval of 

new animal drugs. It does not establish 

any rights for any person and is not 

binding on FDA or the public. You can 

use an alternative approach if it satisfies 

the requirements of the applicable 

statutes and regulations. 

II. Paperwork Reduction Act of 1995 

While this guidance contains no 

collection of information, it does refer to 

previously approved FDA collections of 

information. Therefore, clearance by the 

Office of Management and Budget 

(OMB) under the Paperwork Reduction 

Act of 1995 (PRA) (44 U.S.C. 3501– 

3521) is not required for this guidance. 

The previously approved collections of 

information are subject to review by 

OMB under the PRA. The collections of 

information in 21 CFR part 514 have 

been approved under OMB control 

number 0910–0032. 

III. Electronic Access 

Persons with access to the internet 

may obtain the guidance at either 

https://www.fda.gov/AnimalVeterinary/ 

GuidanceComplianceEnforcement/ 

GuidanceforIndustry/default.htm, 

https://www.fda.gov/regulatoryinformation/search-fda-guidancedocuments, or https://

www.regulations.gov. 

Dated: July 8, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–14938 Filed 7–13–21; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2020–N–1644] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Medical 

Conference Attendees’ Observations 

About Prescription Drug Promotion 

AGENCY: Food and Drug Administration, 

Health and Human Services (HHS). 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a proposed collection of 

information has been submitted to the 

Office of Management and Budget 

(OMB) for review and clearance under 

the Paperwork Reduction Act of 1995. 

DATES: Submit written comments 

(including recommendations) on the 

collection of information by August 13, 

2021. 

ADDRESSES: To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be submitted to https://

www.reginfo.gov/public/do/PRAMain. 

Find this particular information 

collection by selecting ‘‘Currently under 

Review—Open for Public Comments’’ or 

by using the search function. The title 

of this information collection is 

‘‘Medical Conference Attendees’ 

Observations About Prescription Drug 

Promotion.’’ Also include the FDA 

docket number found in brackets in the 

heading of this document. 

FOR FURTHER INFORMATION CONTACT: Ila 

S. Mizrachi, Office of Operations, Food 

and Drug Administration, Three White 

Flint North, 10A–12M, 11601 

Landsdown St., North Bethesda, MD 

20852, 301–796–7726, PRAStaff@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: In 

compliance with 44 U.S.C. 3507, FDA 

has submitted the following proposed 

collection of information to OMB for 

review and clearance. 

Medical Conference Attendees’ 

Observations About Prescription Drug 

Promotion 

OMB Control Number 0910—NEW 

Section 1701(a)(4) of the Public 

Health Service Act (42 U.S.C. 

300u(a)(4)) authorizes FDA to conduct 

research relating to health information. 

Section 1003(d)(2)(C) of the Federal 

Food, Drug, and Cosmetic Act (FD&C 

Act) (21 U.S.C. 393(d)(2)(C)) authorizes 

FDA to conduct research relating to 

drugs and other FDA regulated products 

in carrying out the provisions of the 

FD&C Act. 

The Office of Prescription Drug 

Promotion’s (OPDP) mission is to 

protect the public health by helping to 

ensure that prescription drug promotion 

is truthful, balanced, and accurately 

communicated. OPDP’s research 

program provides scientific evidence to 

help ensure that our policies related to 

prescription drug promotion will have 

the greatest benefit to public health. 

Toward that end, we have consistently 

conducted research to evaluate the 

aspects of prescription drug promotion 

that are most central to our mission. Our 

research focuses in particular on three 

main topic areas: Advertising features, 

including content and format; target 

populations; and research quality. 

Through the evaluation of advertising 

features, we assess how elements such 


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